Statistical Programmer - Katalyst Healthcares & Life Sciences
San Francisco, CA 94102
About the Job
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Lead the development, validation, and maintenance of statistical programs using SAS to generate tables, listings, and figures (TLFs) for clinical trial data analysis.
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Develop and maintain SDTM domains in accordance with CDISC guidance.
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Create and optimize ADaM datasets, Tables, Figures, Listings (TFLs) and Analysis content.
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Support the creation of statistical outputs for clinical study reports (CSRs), regulatory submissions, and publications.
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Prepare documentation for regulatory submissions, including electronic submissions to the FDA and other global health authorities
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Perform data cleaning, validation, and preparation tasks to ensure high-quality datasets for analysis.
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Prepare and maintain thorough documentation of programming activities, including specifications, programming code, and validation reports.
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Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.
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Establish and implement statistical programming standards and comply with industry standards and regulatory requirements among project team members and across all studies.
- Minimum of a bachelor's degree required; MS degree is preferred. (statistics, biostatistics, or closely related field)
- 5 years' experience with SAS and clinical programming within the biotech / pharmaceutical industry.
- Proficiency in SAS programming, including experience with SAS macro language, data step programming, and PROC SQL.
- Strong knowledge of CDISC and CDASH standards, including SDTM and ADaM datasets, and experience with regulatory submission requirements.
- Experience with clinical trial data and understanding of the drug development process.
- Proficiency in industry standards, medical terminology, and clinical trial methodologies.
- Excellent problem-solving skills and attention to detail, with the ability to work independently and manage multiple projects simultaneously
- Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
